We founded Epis Data with a simple belief: data should never slow down discovery.
Our purpose is to help agencies save lives, accelerate breakthroughs, and improve care by ensuring every dataset is reliable, reproducible, and regulator-ready.
This mission alignment means that when agencies modernize their data systems, push for faster trial outcomes, or demand compliance with evolving standards, Epis is already prepared to deliver.
● Clinical Data Management – From study start-up through database lock, we manage EDC builds, data cleaning, reconciliation, and eTMF oversight.
● Biostatistics – Expert study design, SAP development, and safety/efficacy analyses co-authored with researchers to meet regulatory scrutiny.
● Statistical Programming – Submission-grade outputs including CDISC SDTM/ADaM datasets, TLFs, ISS/ISE deliverables, and complete metadata packages (define.xml, cSDRG, ADRG).
● Regulatory Submissions – Proven delivery of FDA, EMA, and PMDA-compliant documentation packages that pass conformance checks.
● Healthcare IT & Analytics – Data harmonization, reporting, and decision-support tools that strengthen oversight and public-health missions.
● Staffing & Project Support – Flexible augmentation, surge capacity, and remediation of delayed or challenged projects keep federal programs on track.
Our Impact at a Glance
● 200+ clinical studies supported with full biometrics lifecycle.
● 25+ global regulatory submissions delivered to FDA, EMA, PMDA.
● 20+ years average team experience in biostatistics, data management, and regulatory compliance.
● Recognized as a Small Business under SBA standards.
